Navigation Links
FDA Approves New Drug to Fight Advanced Prostate Cancer
Date:5/15/2013

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration announced Wednesday that it has approved a drug to help men with advanced prostate cancer whose disease has spread to the bones.

The drug, Xofigo, is targeted to patients with late-stage, metastatic disease that has spread to the bones but not to other organs, the FDA said in a news release. It is meant for patients who have already undergone surgery and/or drug therapies such as hormone-based treatments.

The FDA said Xofigo, marketed by Wayne, N.J.-based Bayer Pharmaceuticals, was approved more than three months ahead of the original August 2013 deadline the agency had set for a complete review. Instead, the drug was reviewed under the agency's "priority" review program, designated for medicines that appear safe and effective in a context where no good alternative therapy exists.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained in the news release.

In a clinical trial involving more than 800 men with symptomatic prostate cancer that was resistant to hormonal therapy and had spread to the bones, men on Xofigo survived a median of 14 months compared to a little over 11 months for men taking a placebo. Side effects from Xofigo included nausea, diarrhea, vomiting and swelling of the legs and feet. Low levels of red and white blood cells, as well as platelets, were also reported among some patients taking Xofigo, the FDA said.

Pazdur noted that "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer." The other drug, Xtandi, was approved by the FDA last August for men with hormone treatment-resistant prostate cancers that have spread or recurred, and who had previously been treated with the drug docetaxel.

According to the American Cancer Society, prostate cancer remains the leading cancer type among men outside of skin cancer, and about one man in every six will develop the illness during his lifetime. Caught early, it is often curable. About 239,000 new cases of prostate cancer are diagnosed among American men each year, and nearly 30,000 men die from the disease annually.

More information

Find out more about prostate cancer at the U.S. National Cancer Institute.

-- E.J. Mundell

SOURCES: May 15, 2013, news release, U.S. Food and Drug Administration; American Cancer Society


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Approves Morning-After Pill Without a Prescription
2. FDA Approves New “Gummy Bear” Breast Implants, But Albany Plastic Surgeon Urges Caution
3. FDA Approves 1st in New Class of Type 2 Diabetes Drugs
4. FDA Approves New Multiple Sclerosis Drug
5. FDA Approves Drug for Older Women Experiencing Painful Sex
6. FDA Approves Bionic Eye to Help Against Rare Vision Disorder
7. MSSD Approves of the Encinitas School District’s Holistic Education
8. FDA Approves 3 New Drugs for Type 2 Diabetes
9. FDA Approves 1st Skin Patch to Combat Migraines
10. Environmental Protection Agency Approves MOMS by OdorXit as a Disinfectant
11. FDA Approves New Type of Flu Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves New Drug to Fight Advanced Prostate Cancer
(Date:5/29/2016)... (PRWEB) , ... May 29, 2016 , ... Whole Health ... Amazon.com, their new KlipPro KP-240L clipper is available to the public. This is an ... is substantially wider than the average clipper. , Everything about this product is concentrated ...
(Date:5/28/2016)... ... May 28, 2016 , ... After a year and a half of planning the ... extraordinary event. The Multiple Pathways of Recovery Conference was held May 2 -4, 2016 ... and the United Kingdom came together to explore the many pathways individuals use to get ...
(Date:5/27/2016)... ... , ... W.S. Badger Co. Inc ., the maker of certified organic ... one of the best small businesses for new dads by Fatherly, the digital lifestyle ... providing progressive benefits to new parents on the organization’s 2016 Best Places to ...
(Date:5/27/2016)... ... May 27, 2016 , ... In response ... many who are unaware of the plight of aphasia. In collaboration with the ... “Stroke Awareness” campaign. , The link between stroke and aphasia is relatively unknown, ...
(Date:5/27/2016)... ... ... With a team of certified experts, Validation Center is ... GMP accreditation, Validation Center is also a registered authority of the international system ... Validation Center is ISO17025 accredited and only offers its clients the latest technology, ...
Breaking Medicine News(10 mins):
(Date:5/27/2016)... , May 27, 2016 LabStyle ... Dario™ Diabetes Management Tool, today announced that the Company,s Chief ... Marcum MicroCap Conference being held June 1-2 in ... being held June 7-9 in Los Angeles, CA. ... discuss recent corporate and operational milestones, including the U.S. FDA ...
(Date:5/27/2016)... Kitov Pharmaceuticals ... late-stage drug development, today announced the completion of ... batches required for registration of KIT-302 with the ... Kitov,s announcement in December 2015, that ... primary efficacy endpoint. "We are fortunate ...
(Date:5/26/2016)... 2016 According to a new market ... - U.S. Industry Analysis, Size, Share, Growth, Trends, and Forecast ... U.S. was valued at US$ 5.89 Bn in 2014 and ... 2015 to 2023 to reach US$ 7.99 Bn in 2023. ... emerging needle free drug delivery devices and the market is ...
Breaking Medicine Technology: